Testing | mddionline.com

Is Your Validation Master Plan in Shape?

May 27, 2015

You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one?

Quality Spending Increasing in Medtech

Mar 30, 2015

Medical device companies are spending more on quality functions, as a result of regulations, compliance, and acquisitions.

Validate Your Process Using Design of Experiments

Jan 27, 2015

Design of experiments enables engineers to demonstrate or understand a process while providing information required for achieving regulatory compliance.A valuable method for predicting process variability, design of experiments (DOE) allows...

How to Detect Laser-Weld Defects in Pacemaker Casings

Jan 14, 2015

Acoustic imaging is a nondestructive technique for detecting voids in titanium pacemaker casings.

What Types of Biocompatibility Testing Do You Need to Perform?

Nov 19, 2014

On Thursday, December 4 at BIOMEDevice San Jose, Thor Rollins, in vivo biocompatibility section leader at Nelson Laboratories Inc. (Salt Lake City, UT), will speak on "Materials Selection and Sampling Techniques for Biocompatibility (ISO 10993)."...

Alpha Medical Cited by FDA on Balloon Catheter Quality

Nov 04, 2014

A nine-day FDA inspection at Alpha Medical Instruments in Mission Viejo, CA, in August found Quality System Regulation violations in the firm’s manufacturing of angiographic balloon catheters.

FDA Finds QSR Breaches at South Korea’s Infopia

Nov 04, 2014

An FDA inspection at Infopia in Anyang-si, South Korea, has found Quality System Regulation violations in the firm’s manufacturing of several glucose and lipid devices.

Medical Device Quality Planning

Oct 24, 2014

Why does something so simple become so difficult?

Integrating ERP and Quality Management in the Cloud

Oct 09, 2014

To compete, grow, and innovate, manufacturers should adopt a cloud-based enterprise resource planning system that integrates quality management functionality.

Express Diagnostics Cited on Quality Issues

Oct 02, 2014

The Blue Earth, MN, firm's violations include failing to establish adequate procedures for acceptance of in-process product and failing to establish adequate procedures for corrective and preventive action.